Ibuprofen / Pseudoephedrine Oral Capsule

Brand(s)
Advil Cold and Sinus
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Pfizer Consumer Healthcare (2011-06-30)
Oldest Current Product
2002-05-30
License(s)
NDA
RxNORM
ORAL CAPSULE\IBUPROFEN:PSEUDOEPHEDRINE
FDAOB
ORAL\CAPSULE\IBUPROFEN: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Active
ORAL\CAPSULE, LIQUID FILLED\IBUPROFEN: PSEUDOEPHEDRINE HYDROCHLORIDE
SPL Moiety
ORAL\CAPSULE, LIQUID FILLED\IBUPROFEN: PSEUDOEPHEDRINE

product(s) by strength(s)

ibuprofen 200 mg / pseudoephedrine hydrochloride 30 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005730184Advil Cold and SinusNDAPfizer Consumer Healthcare2002-05-30IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDEORALCAPSULE, LIQUID FILLEDNDA0213740da9ed22-bfb4-d61b-110b-0c7760332a98

application(s)

#idtitleapplicantapprovedapproved drug
1NDA021374ADVIL COLD AND SINUSPFIZER INC2002-05-30NDA021374_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021374_001OTCIBUPROFEN (EQ 200MG FREE ACID AND POTASSIUM SALT), PSEUDOEPHEDRINE HYDROCHLORIDE (30MG)ORALCAPSULETrue2002-05-30ADVIL COLD AND SINUS

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
10da9ed22-bfb4-d61b-110b-0c7760332a98 (view SPL)ADVIL COLD & SINUS(ibuprofen and pseudoephedrine HCl)otcHuman OTCPfizer Consumer Healthcare2011-06-304005730184

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII